A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Wenda Pharma Technology LTD.

About this trial

The purpose of the study is to evaluate the experimental medication WD-890 compared to placebo in participants with moderate-to-severe plaque psoriasis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female participant aged 18 to 75 years(inclusive)at the time of informed consent.

Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.

Body surface area (BSA) ≥10%, Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization

Disqualifiers

Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)

Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted

Class III or IV congestive heart failure by New York Heart Association Criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug:WD-890

    Drug

    WD-890 tablet will be administered orally.

  • Drug: placebo

    Drug

    Placebo tablet will be administered orally.

Treatment groups

375 Participants
are divided into 2 treatment groups
Group A: Group 1:WD-890Experimental treatment 1 intervention
Group B: Group 2: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 16

Time frame
Screening up to Week 16
2

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16

Time frame
Screening up to Week 16

Secondary outcomes

1

Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

Time frame
Screening up to Week 52
2

Percentage of Participants Achieving PASI 90 Score at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

Time frame
Screening up to Week 52
3

Percentage of Participants Achieving PASI 100 Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

Time frame
Screening up to Week 52
4

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.

Time frame
Screening up to Week 52

Other outcomes

Sponsors and contacts

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